Biopharma · FDA Approvals · Stock
AXGN Axogen
Axogen Inc is engaged in the science, development, and commercialization of technologies for peripheral nerve regeneration and repair. The company provides clinically and economically effective repair solutions for surgeons and health care providers. Its products include Avance Nerve Graft, Axoguard Nerve Connector, Ax…
Assets on file: acellular nerve allograft-arwx, NerveTape
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Recent first-hand events
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AXGNAxogenAxogen Completes Acquisition of BioCircuit and NerveTape for Sutureless Nerve Repair
Axogen completed the acquisition of BioCircuit Technologies, adding the FDA-cleared NerveTape device for sutureless peripheral nerve repair to its portfolio. The deal is expected to contribute $6M in Q4 2026 and $34M in 2027 revenue (not in prior guidance) while maintaining at least 73% gross margin and free-cash-flow positivity for 2026. This expands Axogen's peripheral-nerve-repair offerings and addressable market via its existing sales and contracting infrastructure.
AXGNAxogenAxogen receives FDA approval for AVANCE acellular nerve allograft
The FDA approved the BLA for AVANCE, converting it from a human tissue product to a licensed biologic. This approval covers sensory nerve discontinuities ≤25 mm outright and >25 mm plus mixed/motor discontinuities under accelerated approval, contingent on confirmatory trials. Commercial availability of the licensed product is expected early Q2 2026.
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